Exploring the Effectiveness of Intelligent Audiovisual Interventions in Delirium, Agitation, and Pain Among Middle Aged and Elderly Patients in Emergency Intensive Care Units: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- Incidence of Delirium Assessed Using the CAM-ICU-7
研究概览
简要总结
The goal of this nonrandomized, quasi-experimental clinical trial is to evaluate whether an intelligent audiovisual intervention can prevent delirium and reduce delirium severity, agitation, and pain among adults aged 55 years or older admitted to an emergency intensive care unit (EICU). The main questions it aims to answer are:
Does the intelligent audiovisual intervention reduce the incidence and severity of delirium compared with routine care? Does the intervention improve agitation and pain scores compared with routine care?
Researchers will compare participants receiving the intelligent audiovisual intervention plus routine care with participants receiving routine care alone. Participants will be assigned according to the week of EICU admission: those admitted during odd-numbered weeks will receive the intervention, while those admitted during even-numbered weeks will receive routine care.
Participants in the intervention group will:
View a structured audiovisual program containing a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital.
Receive the intervention for 2 minutes per session, 3 times daily for 2 consecutive days, beginning within 24 hours after EICU admission.
Participants in both groups will undergo assessments of delirium, agitation, and pain 3 times daily for 2 consecutive days. Delirium incidence and severity will be assessed using the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7). Agitation will be evaluated using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using either the Numerical Rating Scale (NRS) or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 years or older.
- •Admitted to the emergency intensive care unit within the previous 24 hours.
- •No delirium at baseline, defined as a negative Confusion Assessment Method for the Intensive Care Unit assessment and a CAM-ICU-7 score of 0-
- •Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥
- •Sufficiently alert to communicate, with a Glasgow Coma Scale score of E4V4-5M6 or E4VTM
- •Diagnosed with an infection or an infection-related critical illness, such as sepsis, urinary tract infection, or pneumonia.
排除标准
- •Diagnosed visual or hearing impairment that would interfere with receiving the audiovisual intervention.
- •History of substance abuse.
- •History of psychiatric illness.
- •Moribund status, receipt of a palliative care consultation, or an expected survival of 7 days or less.
- •Unable to communicate in Mandarin Chinese or Taiwanese Hokkien.
- •No family caregiver available to participate in preparation of the audiovisual intervention.
- •History of surgery within the previous 7 days.
- •Montreal Cognitive Assessment (MoCA) score <23.
研究组 & 干预措施
Intelligent Audiovisual Intervention
Participants will receive routine care plus a structured intelligent audiovisual intervention beginning within 24 hours after admission to the emergency intensive care unit. The audiovisual program includes a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital to provide cognitive orientation cues and emotional support. The intervention will be delivered for 2 minutes per session, 3 times daily (at 7:00 AM, 5:00 PM, and 9:00 PM) for 2 consecutive days. Participants will also receive routine family visiting twice daily.
干预措施: Intelligent Audiovisual Intervention (Behavioral)
Routine Care
Participants will receive routine care without the intelligent audiovisual intervention. Routine care includes standard medical and nursing care and family visiting twice daily, at 11:00 AM and 7:00 PM, for 1 hour per visit. Participants will undergo the same assessments of delirium, agitation, and pain as those in the experimental arm.
结局指标
主要结局
Incidence of Delirium Assessed Using the CAM-ICU-7
时间窗: From baseline through the end of Day 2; assessed 3 times daily
Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7). The outcome will be reported as the percentage of participants with at least one positive CAM-ICU-7 assessment during the 2-day assessment period.
Change From Baseline in Delirium Severity Assessed Using the CAM-ICU-7
时间窗: Baseline through the end of Day 2; assessed 3 times daily
Delirium severity will be measured using the CAM-ICU-7. Total scores range from 0 to 7, with higher scores indicating greater delirium severity. Scores of 0 to 2 indicate no delirium, 3 to 5 indicate mild to moderate delirium, and 6 to 7 indicate severe delirium. Changes from baseline will be evaluated across the scheduled assessments.
次要结局
- Change From Baseline in Richmond Agitation-Sedation Scale Score(Baseline through the end of Day 2; assessed 3 times daily)
- Change From Baseline in Pain Intensity Score(Baseline through the end of Day 2; assessed 3 times daily)